Bilateral compression device

ABSTRACT

The present invention provides an improved bilateral compression device for post-operative surgical site, the bilateral compression device including a central cavity presented by an outerwall and a circumscribing sidewall, the central cavity in receipt of a post-operative pillow further comprising an outer membrane separated from an inner membrane for exerting a central compressive force and central indentation force deflection towards the post-operative surgical area which varies from a surrounding compression force.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation in part of and claims the benefit ofU.S. non-Provisional Pat. Application No. 15/496,830, which was filed onApr. 25, 2017 which was a continuation of 15/491,583 filed on Apr. 19,2017.

FIELD OF THE INVENTION

The present invention is broadly directed to post operative treatmentdevices and, more particularly, to an improved postoperative bilateralcompression device with contoured surfaces to diminish bruising, andswelling after periocular procedures.

BACKGROUND OF THE INVENTION

Functional eyelid surgery is performed to improve vision and ocularcomfort. When the upper eyelids droop this can obscure the superiorvisual field and when the lower eyelid flips away from the globe(ectropion) or towards the globe (entropion) it causes the eye to becomered, watery, irritated and the vision to blur. Eyelid changes are morecommon in our aging population. It is also estimated that cosmeticeyelid surgery is the third most popular elective cosmetic procedure inthe United States and it is anticipated that functional and cosmeticeyelid procedures will continue to grow in demand in the coming yearsbased on an aging population and on the excellent treatment successrates. Other non-invasive periocular procedures such as lasertreatments, radiofrequency treatments, ultrasonic treatments, andinjections with Botox and filler injections have also become morepopular in recent years.

As a result of the increased number of periocular procedures, manypeople will experience the typical post-operative problems of swelling,and bruising caused by leakage of blood and serous fluid frommicroscopic capillaries which are unavoidable cut during surgery ornon-invasive procedures. Studies have shown the top concern of patientsbefore and after undergoing periocular procedures is bruising andswelling. Bruising of the eyelids may contribute to poor lid globeapposition which may lead to blurred vision and cause additional delaysin the patient recovery. Bruising and swelling is typically ratelimiting to returning to work or to a normal social calendar after aperiocular procedure.

The vast majority of periocular procedures are bilateral with theminority being performed on only one side. An ideal post operativedevice to reduce bruising and swelling should be easily used in themajority of cases which are bilateral as well as adaptable to theminority of cases which are unilateral. The eyelid splint described inpatent number 4907580 is a unilateral device and would not beappropriate for most bilateral eyelid procedures.

In typical post-treatment care, it is recommended to utilize the PRICEprincipals, namely to protect, rest, ice, compress and elevate aroundthe affected areas to help that area heal. However, the facial anatomyassociated with the periocular region presents unique difficulties whichare affected by surrounding tissue, cartilage and bones which interferewith the PRICE techniques. In addition, maintaining compression and iceon the ophthalmic postoperative areas can create physical andpsychological discomforts upon the treated patient and the time honoredrecommendation to apply ice to the eyelids has not actually proveneffective in controlled studies.

Because of the large vascular network around the periocular region, thisarea is subject to swelling and bruising which increases after anyprocedure which damages the microscopic network of capillaries. It wouldtherefore be beneficial to have a device for use during thepostoperative process which helps reduce bruising and swelling of theeyelids and area surrounding the treatment area. The eyelids have arobust vascular supply and only a thin distensible layer of skin that isnot effective in concealing bruising and this tissue is easilydistensible encouraging swelling. For many years eyelid surgeons haverecommended frequent ice compresses for the first few days afterperiocular treatment to minimize bruising. For many injuries to manyareas of the body ice and cooling therapies are thought to help decreaseblood loss, bruising, swelling, pain sensation and to speed the rate ofrecovery. In the only published controlled studies on the use of icecompresses after eyelid surgery, ice was found to be ineffective atdecreasing bruising and swelling and to not have a clinicallysignificant impact on post-operative pain. So the almost universallyrecommended method of reducing bruising and swelling and pain aftereyelid procedures has not proven effective when put to a scientifictest. This is probably because although ice cooling can cause somevasoconstriction which should reduce bruising and swelling it also hasbeen shown in well controlled scientific studies to markedly increasebleeding time as it slows down how long it takes the blood to clot.

Compression is one of the physical methods recommended by the PRICEprinciples. However, the regional anatomy of the periocular region makescompression difficult and, in some situations, dangerous. There is aneed for an improved compression device which includes a periocularpatch with a precise adjustment mechanism to control the pressureapplied to areas around the periocular region allowing the improvedcompression device to apply a minimum yet effective pressure over theeyelids. For example, the capillaries in human skin are part of alow-pressure system with pressures of less than 12 mm Hg typicallypresent in healthy young adults. Application of external pressure to theskin which is greater than the pressure inside the microscopiccapillaries may cause the capillaries to collapse and to cease toprovide nourishment for the surrounding tissue. This phenomenon may leadto formation of pressure ulcers of the eyelids similar to the ulcerswhich occur on the sacrum and heals of those confined to bed and unableto roll about thus redirecting pressure to various parts of the skin.Similarly applying overly tight compressive dressings which exceed thecapillary perfusion pressure may result in severe ischemic pain andnecrosis and scarring of the underlying skin. This has been respondedwhen overly tight dressings applied to the lower face or forehead aftersurgery

Some prior attempts include devices which exert “no less than 23 mm Hgand no more than 40 mm Hg” of pressure to the overlying skin. This is2-3 times the capillary perfusion pressure and this pressure may lead tonecrosis of the skin and scarring. Some additional attempts atovercoming these pressure issues include use of devices which present aspace or vaults over the eyelids which have limited ability to applypressure to the eyelid area and therefore to help reduce bruising orswelling of the eyelids.

External pressure applied to the eyelid is transmitted to the eyeball inthe form of an increase in intraocular pressure. The normal intraocularpressure is <20 mm Hg and increasing intraocular pressure substantiallyabove this level by applying an external pressure may increase theintraocular pressure. Increased intraocular pressure can cause opticnerve damage and blindness. Therefore, there is a desire for a devicewhich applies a controlled external pressure of less than 12 mm Hg tothe eyeball and nearby skin.

One of the most feared complications of periocular treatments orinjections given in the periocular region is hemorrhaging of an arteryor arteriole behind the eye. The area behind the eye is a closedcompartment called the orbit lined on all sides except the side coveredby the eyelids by bones. The bony orbit can only expand toward thedistensible eyelids in the case of an orbital hemorrhage to relievepressure. The eye can move forward about 1.2 cm in this situationsignificantly increasing the volume of the orbit and decompressing theobit. However, if an artery within the orbital compartment begins tobleed during or after a procedure the pressure in the orbitalcompartment can exceed the perfusion pressure of the eye. If this lastsfor even a few minutes, blindness may result. This is one of the leadingcauses of vision loss after periocular procedures and can happen evenwith an injection.

By way of example, a common maneuver performed in the emergency room inthis situation is called inferior canthotomy and cantholysis which is anemergent minor surgical procedure performed at the patient’s bedside torelease the eyelid so the globe can move forward and decompress.Conversely, an external compression device which applies a pressure tothe eyelids over the underlying eye can prevent the eye from movingforward during retrobulbar hemorrhage and thus prevents the orbit fromdecompressing. At the conclusion of a surgical procedures, a surgeon maytape on a pressure patch. If the pressure patch prevents the eye frommoving forward or decompressing, a patient could lose vision from aretrobulbar hemorrhage.

Application of pressure to the bony orbital rim may help diminish thepotential loss from a retrobulbar hemorrhage because it is not typicallytransmitted to the orbital compartment and therefore does not typicallyprevent the eye from moving forward. By providing a periocularcompressive device that applies most of the compressive forceperipherally over the orbital rim and less compressive force centrallyover the eyelids. If one reviews FIGS. 1-3 of patent number 4907580 itis evident from the shape of that device a significant amount ofpressure would be applied to the central eyelid skin and this wouldlikely contribute to a rise in orbital pressure and blindness in thecase of a retrobulbar hemorrhage. Even in the absence of an orbitalhemorrhage such a forceful central compression of 23-40 mm Hg wouldincrease the intraocular pressure and could damage the optic nerve as isroutinely observed in glaucoma. Use of this device for post proceduremanagement of patients in some situations may be considered malpractice.

It would be beneficial to provide a post procedure compression devicewhich allows for small adjustments to the compressive pressure to beless than the capillary perfusion pressure (approximately less than 12mm Hg) and thus avoiding skin necrosis. It would also be beneficial toif the post procedure compression device applies less pressure over theeye than over the orbital rim so as to not transmit excessive pressureto the inside of the eye. Another desirable feature of a post procedurecompression device would also allow for forward movement of the eye fordecompression within the orbital space such as in the case ofretrobulbar hemorrhage.

Too much pressure applied over the central eyelid can prevent forwardeye movement such as in the case of retrobulbar hemorrhage. A measure ofhow much pressure must be applied to indent an object is the indentationforce deflection (IFD). A high indentation force deflection means thatit takes a lot of pressure to compress an object a little as is the casewith a very firm pillow. A high IFD device applied over the centraleyelid skin would prevent the eye from easily moving forward in the caseof a retrobulbar hemorrhage. Thus, it would be desirable to provide apost procedure compressive device with a low IFD presented along theperiocular region to allow forward eye movement for decompression in thecase of an orbital hemorrhage.

In the past, one solution has been to apply compressive eye patchespostoperatively to the post-operative surgical area, e.g. the perioculararea, with adhesive tape to help with recovery. However, eye patches arenot acceptable for cases when both eyes are undergoing recovery for anextended period of time because they temporarily blind the patient andthis can create additional anxiety issues and physical limitations forthe patient during the recovery process. Releasing patients to homeafter periocular treatments with taped-on compressive dressings overboth eyes may result in greater risk of falls and other injuries. Thiscomplication can be avoided with a post procedure compressive devicewhich is worn while the patient is seated or supine but which is easilyremoved allowing vision when the patient walks about. It is alsodifficult to adjust the precise tension such a patch applies to theskin. In addition, a taped-on patch generally has little flexibility,presenting a high IDL and thus does not readily allow the eye to moveforward in the case of retrobulbar hemorrhage.

Accordingly, there is a need for an improved post procedure perioculardevice which safely applies a pressure of less than 12 mm Hg to theperiocular skin, applies minimal yet effective pressure to the eyelidskin overlying the globe, has a low IFD in the areas which contacts theskin overlying the globe, is removable so the patient can see to walkabout, but when in place providing desired bilateral or unilateralcompression as needed to assist the patient during the recovery periodand addresses at least a portion of the aforementioned shortcomings.

SUMMARY OF THE INVENTION

The present invention includes an improved bilateral compression devicefor post-treatment care of the periocular region. The bilateralcompression device including a central cavity presented by an outerwalland a circumscribing sidewall, said central cavity in receipt of apostoperative pillow further comprising an outer membrane separated froman inner membrane for exerting a central compressive force towards thepost-operative surgical area which varies from a surrounding compressionforce. The central compressive force is less than the surroundingcompressive force and the portion of the device creating the centralcompressive force is of low IDL. The device also provides cooling andcomfort by adjusting to the contour of the wearer and allowing for easyremoval and precise adjustments to the applied compression around theperiocular area.

Various objects and advantages of the present invention will becomeapparent from the following description taken in conjunction with theaccompanying drawings wherein are set forth, by way of illustration andexample, certain embodiments of this invention. The drawings submittedherewith constitute a part of this specification, include exemplaryembodiments of the present invention, and illustrate various objects andfeatures thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a left side perspective view of an exemplary embodiment ofbilateral compression device.

FIG. 2 is an exploded side perspective of the exemplary embodiment ofFIG. 1 .

FIG. 3 is a rear perspective of the exemplary embodiment of FIG. 1 .

FIG. 4 is a side perspective of an alternative embodiment of thebilateral compression device.

FIG. 5 is a rear perspective of the alternative embodiment of FIG. 4 .

FIG. 6 is a side perspective of a second alternative embodiment of thebilateral compression device.

FIG. 7 is a rear perspective view of an alternative embodiment of anonogram illustrated along a portion of the headband with spacedindicia.

FIG. 8 is a chart illustration of the nonogram reflecting the exertedcompression as a relationship between the head circumference and thenumerical indicia illustrated on the headband.

DETAILED DESCRIPTION OF THE INVENTION

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention, which may be embodied in variousforms. Therefore, specific structural and functional details disclosedherein are not to be interpreted as limiting, but merely as a basis forthe claims and as a representative basis for teaching one skilled in theart to variously employ the present invention in virtually anyappropriately detailed structure.

Referring to the drawings in more detail, the reference numeral 10generally refers to an embodiment of the present invention, a bilateralcompression device designed to be worn on the head of the patient afterperiocular procedures to assist in the healing process. The bilateralcompression device 10 includes a central cavity 20 presented by anouterwall 18 and a circumscribing sidewall 12 which generally extendsalong the outerwall 18.

Example materials which may be used for the outerwall 18 andcircumscribing sidewall 12 include but are not limited to plastics andmetals. In one embodiment, the outerwall 18 and circumscribing sidewall12 may comprise a single rigid piece for example using an injectionmolding process. In one exemplary embodiment, the bilateral compressiondevice 10 may utilize a goggle like one commercially available fromSmith Optics, Inc. In yet another exemplary embodiment, the outerwall 18and circumscribing sidewall 12 may be made from different rigidmaterials, each having different properties and different shapes asdesired.

The circumscribing sidewall 12 generally extends from the outerwall 18providing a rim and in one embodiment may present a pair of slottedopenings 14 which generally receive an elastic band 16, also referred toas a headband, for easy removal and adjustment of the bilateralcompression device 10. In one embodiment, the outerwall 18 and sidewall12 are rigid structures to direct the applied force along the bonyorbital rim and surrounding structure, avoiding the upper and lowereyelid which overlies the eye. In one embodiment, the outerwall 18 andsidewall 12 are sufficiently dimensioned to apply pressure along theportions of the face typically impacted by bruising after periocularprocedures. By way of example, the outerwall 18 and sidewall 12 mayextend 2 cm above the superior orbital rim, 2 cm lateral to the orbitalrim, 3 cm below the orbital rim and medially over the base of the nose.Alternatively, the headband 16 may be attached to clips inserted throughcircumscribing sidewall 12. The elastic band 16 also allows thebilateral compression device 10 to remain on during the night while thepatent sleeps. Generally, the elastic band 16 is provided that generallyincludes an elastic or resilient material to allow stretching of theelastic band 16 as desired for placement or removal of the bilateralcompression device 10. Generally, the elastic band 16 with the outerwall18 and circumscribing sidewall 12 use a micro-adjustment mechanism 40 topresent a biased contoured surface for applying a precisely titratedpressure to a periocular region or post operative region which for atypical user may include the eyelids and the area peripheral to theeyelids. The biased countered surface includes a compressive surfacewhich can extend around the area associated with the eyelids, base ofthe nose and orbital rim, extending at least 2-3 cm peripheral to theorbital rim (not shown).

In some cases, the elastic band 16 may slide upward or downward on theback of the head which may result in elongation of the elastic band 16and thus alter the pressure applied to the post operative surgical siteassociated with the bilateral compression device 10.

The bilateral compression device 10 generally outlines the periocularregion associated with the post-treatment surgical area with thecircumscribing sidewall 12 extending along the outer area of thepost-treatment surgical area. In the depicted embodiment of FIG. 1 , thecircumscribing sidewall 12 extends along the outerwall 18 and presents acontact surface which extends around the optical socket and nose bridgearea and may include a straight line, arc, polygon or irregular shapefor extending along the post-operative surgical area.

The micro adjustment mechanism 40 allows the tension in the elastic band16 to be positionally adjusted in a way which is easily reproducable andmeasurable to carefully titrate the compressive forces exerted by thebilateral compression device 10. Numbered indices of regular intervalsmay be printed along the band 16 allowing for adjustment of the strap toa desired compressive force which does not exceed the capillaryperfusion pressure. A nomogram may be used which allows measurable andeasily repeatable adjustment of the band 16 to provide the desiredcompression based, for example, on the wearer’s head-diameter. Themicro-adjustment mechanism 40 provides an easily measurable band whichassist in providing a safe and effective compression of the periocularregion.

In one embodiment, the nomogram may include a least one set of indiciapositioned along the band 16 with a position indicator 102 configuredfor receiving the band 16 with the indicia 42 spaced there along. By wayof example, the set of indicia 42 may correspond to the headcircumference or correspond to the magnitude of applied compression. Thenomogram may also include various visual elements including color orgraphic elements to indicate that the compression settings are within asafe range versus an unsafe range or a desired range versus an undesiredrange. The micro-adjustment mechanism 40 helps provide a safe andeffective compression of the post procedure compression device.

Generally, the central cavity 20 extends inferiorly from the outerwall18 outwardly along the circumscribing sidewall 12 and is adapted forreceipt of a plurality of membranes. Alternatively, the central cavity20 could include an area, at least partially extended exteriorly throughthe outerwall 18.

An exemplary embodiment of a post-operative pillow 30 is depicted inFIG. 2 and includes an outer membrane 24 separated from an innermembrane 29 by an IFD reducing membrane 28. The IFD reducing membraneprovides a prolapse receiver for receiving the inner membrane 29 a depthof 1.2 cm or more in the event of a retrobulbar hemorrhage to allow forforward movement of the eye. Generally, the recess 31 presents a pair ofshaped passages presenting a passage in which either one or both eyescan prolapse into in the event of a retrobulbar hemorrhage. In oneembodiment of the bilateral compression device 20 the inner membrane 29has plural perforations 90 centrally located along the central portionof the inner membrane allowing for removal of the central portion suchthat when they are removed the void created in the inner membrane 89lines up with the recess present in the IFD reducing membrane 28. Oncethe central portion is removed from the inner membrane, the light mayenter through the central portion allowing for visual communicationtherethrough. In some situations, it may be beneficial to remove thecentral portion or only one side of the central portion, where forexample, it is desirable to apply pressure to one eye after a unilateraltreatment while allowing vision through the other eye.

Generally, the post-operative pillow 30 is configured for receipt by thecentral cavity 20. In operation, the post-operative pillow 30 providesmultiple compressive forces upon the post-operative surgical area. Inthe depicted embodiment of FIG. 2 , the post-operative pillow 30provides a reduced compressive force along a central area 31 within saidIFD reducing membrane 28 having a left and right side, also referred toas a pair of recesses. In addition to a reduced central compressiveforce the recess in the IFD reducing membrane reduces the central IFD.Generally, the IFD reducing membrane 28 has a greater compressive forceextended outwardly from the opening associated with the recess 31towards the facial area surrounding the post-operative surgical area,less force and lower IFD being applied along the recess 31 associatedwith the delicate facial area such as the area associated with thewearer’s eyelid and globe tissue. While the embodiment depicted in FIG.2 generally provides for a bilateral compression, or two differentcompression forces and different IFD’s, additional compression forcesand IFD’s may be utilized in the present invention as desired forselectively safely reducing the swelling and discomfort associated withthe post-operative surgical area to assist in the healing process.

The compression forces exerted upon the post-operative surgical area bythe bilateral compression device 10 generally correspond to theproperties of the post-operative pillow 30. Generally, two compressionforces and IFD’s are provided, a central compression force with low IFDand a surrounding greater compression force. The central compressionforce corresponds to the recess 31, while the surrounding compressiveforce corresponds to the IFD reducing membrane 28. Thus, the compressionforces and IFD exerted upon the post-operative surgical area vary by theconfigured recess 31 and the selected IFD reducing membrane 28.Generally, the desired compression for the central compression force isless than the pressure from the surrounding compression force. Therecess 31 is configured to reduce the central compression force anddecrease the IFD thus limiting resistance should the globe need to moveforward to decompress the orbital compartment in the case ofpostoperative orbital hemorrhage.

The outer membrane 24 is generally an opaque or translucent rigidmaterial which is configured for placement between the outerwall 18 andthe central cavity 20. The outer membrane 24 may also provide a moisturebarrier to prevent any unwanted condensation within the central cavity20 during use. The outer membrane 24 depicted in FIG. 2 , generally hasa continuous layer which is adapted for placement on the outerwall 18along the inner cavity 20 and for receiving the IFD reducing membrane28. The outer membrane 24 may be secured with, for example, anadditional adhesive layer (not shown) to the IFD reducing membrane 28.The adhesive layer may also be omitted, or otherwise modified as isknown for securing the outer membrane 24 to the IFD reducing membrane28.

The post-operative pillow 30 is configured for receipt within thecentral cavity 20 and generally provides for compression along therelevant facial contours such as the nose bridge, eyelid and/oreye-socket as well as 2-3 cm peripheral to the bony orbital rim (notshown). In the depicted embodiment of FIG. 2 , the post-operative pillow30 generally includes the inner membrane 29 and the IFD reducingmembrane 28. One embodiment of the IFD reducing membrane 28 includesutilization of a generally compressible cellular material which iscompressible, moisture resistant and provides thermal insulation. Thecompressible cellular material associated with the IFD reducing membrane28, when utilized, of FIG. 2 may be used either individually or incombination with different or additional material and either configuredas a continuous layer or selectively positioned within the centralcavity 20 to provide the desired protection and compressibility at therelevant post-operative location. By way of example, the material usedfor the IFD reducing membrane 28 may be, but is not limited to, alaminated cellular foam material which is moisture resistant and has athickness of at least 1.2 cm thick. An example of commercially availablematerial includes ENSOLITE styles IV1, IV2, IV3, IV4, IV5, GIC OR IVCall manufactured by Ensolite, Inc. of Mishawaka, Ind.

The IFD reducing membrane 28, is configured for placement within thecircumscribing sidewall 12 for receipt by the central cavity 20.Generally, the IFD reducing membrane 28 may be bonded directly to theouterwall 18 to help keep out moisture and maintain the interiortemperature within the central cavity 20 during use.

The inner or facial membrane 29 is generally fabricated from a materialdesigned to cushion the treated area of the patient body after thesurgical procedure. It will be at least ¾” thick allowing it to mold tothe contours of the periocular region. During use, the facial membrane29 may become dirty or soiled from use in connection with thepost-treatment use. In one embodiment the pressure applied by the innerfacial membrane 29 will be utilized to hold sterile disposable eye padsin place by friction. The facial membrane 29 in the depicted embodiment,is substantially planar with a configuration which generally correspondsto the central cavity 20. The inner membrane 29 may be fabricated from avariety of compressible materials which are suitable for treating woundsbut in a preferred situation, it would have a smooth, comfortablesurface which would limit irritation or adhesion to the post-operativearea. By way of example, and not as a limitation, the inner membrane 29may be fabricated from a compressible polyurethane foam material with acoating. Generally, the inner membrane 29 is breathable, flexible with adurable coating having excellent properties which prevent it fromadhering to the recently treated area. In addition, it may include aphase-change water-based coating which may help it maintain an idealcomfortable temperature by acting as a heatsink, and conducting heataway from the surface. Examples may include material made by MentorCorporation under the trade name EPIFOAM or TOPIFOAM. Another examplemay include material made by Bergad Specialty Foam under the trade nameCOOLCELL.

In one embodiment, the inner membrane 29 may also include an innercoating 29 a which is non-absorbent and easily washed to limitabsorption by the inner membrane 29 of ointments used after treatment orblood from absorbing into the material. By way of example, and not as alimitation, the inner coating 29 a may include vinyl which is waterrepellant, easily washed, non-adhesive, and hypoallergenic.

The inner membrane 29 may be secured to the IFD reducing membrane 28 orto the circumscribing sidewall 12 mechanically with, for example, silk,thread or chemically with for example adhesive. The central portion ofthe inner membrane 29 may be removed and frictionally secured to theremainder of the surrounding inner membrane 29 to allow for visualcommunication through the central cavity 20, for example, to allow thepatient to see through the compressive pillow on the side or sides wherea portion of the inner membrane 29 has been removed.

In another embodiment, the inner membrane 29 may be fabricated from foamwith a covering on the side of the foam that touches the skin composedof a gel, graphite or a vinyl mixture or some other material to allowheat to be carried away from the skin and/or to be cooled. It may befabricated from a type of foam that has cooling properties or propertiesof being non-absorbent, hypoallergenic, and easily cleaned independentof any coating.

In one operational embodiment, the circumference of the patient’s headwill be measured immediately before the bilateral compressive device 10is applied using a flexible disposable tape measure. The fasteningmechanism 40 may include one or more position indicators 102 with windowfor receiving the band 16 with the spaced and numbered indices 42.

As illustrated in FIG. 7 a nomogram may be utilized on the headband 16with a plurality of indices 42 spaced along the headband 16 with anadjustable position indicator 102 which indicates the current positionand allows for adjustment of the headband 16. Generally, the headband 16is adjusted to provide the desired compression. Adjustment to thedesired numerical index 42 is based on the head circumference and thelength of the band 16. The selective adjustment allows for precisetitration of the compressive force applied by the bilateral compressiondevice 10 to the user. The fastening mechanism 40 allows for easyremoval of the bilateral compressive device 10 to facilitate vision whenthe patient is ambulatory or to facilitate application of ointments ordrops and the changing of the disposable sterile dressing secured by thebilateral compressive device 10.

An alternative embodiment of the bilateral compression device 60 isillustrated in FIGS. 4-5 with central cavity 20 adapted for receipt ofan alternative inner membrane 89 having optional perforations 90 forselective removal of a portion thereof for visual communication throughthe inner membrane 89. For example, the central portion associated witheach of the left and right side of the inner membrane 89 may each beirregularly shaped or regularly shaped as presented by the pluralperforations 90 spaced along the inner membrane 89 for selective removalof one or both of the left or right side central portion associated withthe recesses 31 to allow for visual communication therethrough. In thisway, the central pressure for at least one side may be reduced and thewearer may be able to see through the inner membrane 89, and the IFDreducing membrane 28 and outer membrane 24 allowing the patient to walkabout with the compressive device in place while simultaneously avoidingvarious injuries.

In another alternative embodiment of the bilateral compression device110 illustrated in FIG. 6 , a shaped headband 116 is provided whichincludes a superior support 130 which is designed to limit unwanteddownward movement of the inferior portion 125 of the band 16 duringwear. Generally, the illustrated shaped headband 116 includes theposition indicator 102, an inferior portion 125, a superior portion 130and an anterior projection 135 joined at a headband junction 122.

During wear, the inferior portion 125 extends rearwardly from theheadband junction 122 to rest on the inferior edge of the occipitalprotuberance of the wearer’s head. The inferior portion 125 generallyprovides posterior and downward bias for the bilateral compressiondevice 110 which is at least partially offset by the superior portion130 to stabilize the bilateral compression device 110 so that downwardmovement on the back of the head is limited.

The superior portion 130 extends from the headband junction 122vertically towards a vertex of the skull and provides vertical biaswhich at least partially vertically supports the bilateral compressiondevice 110. The bias presented by the superior portion 130 at leastpartially offsets the downward bias presented by the inferior portion125. The superior portion 130 and inferior portion 125 are joined topresent a posterior opening 126 which when worn, encircles a portion ofthe occipital and parietal bone associated with the wearer’s head.

The anterior projection 135 extends from the bilateral compressiondevice 110 towards the headband junction 122 and is generally configuredfor receipt by slotted openings 14. The distal or anterior projection135 attaches posteriorly to the headband junction 122 where theanterior, inferior and superior portions 135, 125, 130 intersect. Theproximate posterior end of the anterior projection 135 is locatedopposite the headband junction 122 and near the bilateral compressiondevice 110. In one embodiment, the anterior projection 135 is alignedwith the slotted openings 14 using for example a fastener 124 such as ahook and loop fastener, which is easily adjusted during the initialconfiguration of the bilateral compression device 110 for wear by auser. By aligning the anterior projection 135 with the slotted openings14, the tension on the anterior projection 135 can be easily adjustedand readily secured as desired for applying the selected compressionupon the post operative surgical site. In one embodiment, thecompression can be adjusted to a specific level using a compressionmeasurement device or tool 140. In another embodiment, the compressioncan be adjusted by extending the anterior projection 135 to specificindicia 42 based on head diameter as further described below.

As illustrated in FIG. 6 , an optional compression measurement tool 140may be utilized to configure the alternative bilateral compressiondevice 110, the compression force being measured with, for example, ascale. The embodiment of the fastener 124 associated with the anteriorprojection 135 includes a readily adjustable hook and loop type fastener124. In addition, a receiver 142 is located on the proximate end of theanterior projection 135 which is adapted for connected operation by thecompression measurement tool 140. The receiver 142 may alternatively beassociated with the outerwall 18 or sidewall 12.

The compression measurement tool 140 may be digital or mechanical. Theillustrated compression measurement tool 140 also includes attachingmeans144, like a hook or other fastening structures which can be easilysecured to and removed from the receiver 142. In operation, thecompression measurement tool 140 includes internal force measuringstructure connected to a visual display which indicates an increase ordecrease in compressive force through a mechanical connection to theanterior projection 135.

Alternatively, the proximate end of the anterior projection 135 mayinclude a plurality of numbered indicia 42 spaced along the anteriorprojection where each successive indicia 42 represents an increase incompression according to the well known Hooke’s Law, where the end ofthe anterior projection is stretched or extended from an uncompressedposition to the desired compressed position which will be customized tothe patient’s head diameter, the successive indicia 42 on the anteriorprojection 135 representing the extension directly corresponding to theapplied compressive force according to F = k × e. The numbered indicia42 may be incremented to accommodate configuration of the bilateralcompression device 110 for compression with users having varying headdimensions.

For different types of materials there may be different amounts ofcompression. FIG. 8 shows a representative graph of different pressuresas applied by the headband 16 to different head circumferences based onthe selected numerical indicia 42. In operation, the user can titratethe exhibited compression by select the numerical index 42 whichcorresponds to the desired compression and circumference of the portionof the user’s head which is receiving the portion of the headband 16. Inone example, the nonogram may be utilized in connection with one or moreof the anterior, inferior and/or superior portions 135, 125, 130providing a quick and easy way to adjust the compressive characteristicsof the bilateral compressive device 110.

Alternatively, plural pressure sensors (not shown) may be embeddedwithin or along a surface of the alternative facial membrane 89 foraligning the tension on the shaped headband 116 to a desired pressure.The pressure sensors (not shown) may utilize wireless or wiredcommunication technologies, including Bluetooth, for conveying theassociated tension data as determined by the pressure sensor (not shown)at a location using for example a microprocessor. The conveyed data maybe displayed graphically or numerically on a user device, such as asmartphone, and may include an over-limit or under-limit alarm orsetting.

In an exemplary operation of the use of the compressive measurement tool140, the anterior projection 135 is received by the slotted openings 14and pulled forward. The compression measurement tool 140 is attachedthrough the receiver 142 located on the proximate end of the anteriorprojection 135. The anterior projection 135 is then adjusted until thedesired amount of compression is applied as indicated by the compressionmeasurement tool 140 and then the anterior projection 135 is thensecured to the shaped headband 116 to maintain the desired compression.

The anterior projection 135 upon the post-operative surgical site by thebilateral compression device 110 for proper adjustment of the tensionapplied to the bilateral compression device 10, 110 by the headband 16,116.

Position indicator 102 may be located on, near or between any of theanterior, inferior or superior portions 135, 125, 130 to allow formeasurably adjustment of the shaped headband 116 based in part on thedesired compression and the variable shaped receiver with desirablecomfort to accommodate various dimensions. The shaped headband 116 mayinclude a plurality of position indicators 102 any one of which may beassociated with one or more of the anterior, inferior or superiorportions 135, 125, 130. Generally, the position indicator 102 includes apair of upright members presenting a window for receipt of the band 16and which helps with measurably adjusting the desired compression andupward and outward bias exerted by or upon the bilateral compressiondevice 110.

Position indicators 102 may include length adjustment structuresgenerally known, which may include, but is not limited to, variousmechanical fasteners such as buckles, buttons and hook and loopfasteners. In addition, to adjustment of the bias, the length of atleast one of the anterior, inferior 135, 125 may be adjusted as desiredto titrate the compression force the device 110 delivers, using forexample buckle, hook and loop or other type of length adjustmentstructure as desired for the position indicator 102.

The anterior projection, inferior and superior portions 135, 125, 130may independently or collectively be fabricated from an elastic orflexible material which is adjustable and presents the desired bias tothe bilateral compression device 110 for adjusting the pressure exertedupon a periocular region associated with the post-operative surgicalarea.

It is to be understood that while certain forms of the present inventionhave been illustrated and described herein, it is not to be limited tothe specific forms or arrangement of parts described and shown.

1. (canceled)
 2. A postoperative bilateral compression device comprising: a central cavity presented by an outerwall and a circumscribing sidewall, said circumscribing sidewall presenting a contoured surface which extends along a curved planar surface; an adjustable band secured to said circumscribing sidewall for securing said post-treatment bilateral compression device; a post-operative pillow received by said central cavity; said postoperative pillow further comprising: an indentation force deflection (IFD) reducing membrane configured to present a surrounding compression force directed towards a post-treatment surgical site.
 3. The post-operative bilateral compression device of claim 2 further comprising an outer membrane and an inner membrane positioned adjacent to said outer membrane, wherein said inner membrane further comprises a left side and a right side wherein at least some of one of said left and right side is removable.
 4. The post-operative bilateral compression device of claim 2 further comprising an outer membrane and an inner membrane positioned adjacent to said outer membrane, wherein said inner membrane presents a smooth, non-absorbent, non-stick surface.
 5. The post-operative bilateral compression device of claim 2 further comprising an outer membrane and an inner membrane positioned adjacent to said outer membrane, wherein said inner membrane has a coating.
 6. The post-operative bilateral compression device of claim 2 wherein said post-operative pillow provides a reduced centrally compressive force with a low IFD.
 7. The post-operative bilateral compression device of claim 2 wherein said circumscribing sidewall is configured to present a sealing surface which extends along the post-treatment surgical site.
 8. The post-operative bilateral compression device of claim 2 further comprising an outer membrane and an inner membrane positioned adjacent to said outer membrane, wherein said outer membrane provides visibility through said postoperative bilateral compression device.
 9. The post-operative bilateral compression device of claim 2 wherein said band further comprises a plurality of indicia for adjustment of a centrally compressive force.
 10. The post-operative bilateral compression device of claim 2 further comprising a plurality of pressure sensors embedded in said postoperative pillow for quantitative adjustment of a central compressive force.
 11. The post-operative bilateral compression device of claim 2 wherein said band includes a receiver for receipt of a compression measurement tool for quantitative adjustment of a central compressive force.
 12. A postoperative bilateral compression device comprising: a central cavity presented by an outerwall and a circumscribing sidewall, said circumscribing sidewall presenting a contoured surface which extends along a curved planar surface; an adjustable band secured to said circumscribing sidewall for securing said post-treatment bilateral compression device, wherein said adjustable band further comprises a plurality of indicia for adjustment of a centrally compressive force; a post-operative pillow received by said central cavity; said postoperative pillow further comprising: an indentation force deflection (IFD) reducing membrane configured to present a surrounding compression force directed towards a post-treatment surgical site.
 13. The post-operative bilateral compression device of claim 12 further comprising an outer membrane and an inner membrane positioned adjacent to said outer membrane, wherein said inner membrane further comprises a left side and a right side wherein at least some of one of said left and right side is removable.
 14. The post-operative bilateral compression device of claim 12 further comprising an outer membrane and an inner membrane positioned adjacent to said outer membrane, wherein said inner membrane presents a smooth, non-absorbent, non-stick surface.
 15. The post-operative bilateral compression device of claim 12 further comprising an outer membrane and an inner membrane positioned adjacent to said outer membrane, wherein said inner membrane has a coating.
 16. The post-operative bilateral compression device of claim 12 wherein said post-operative pillow provides a reduced centrally compressive force with a low IFD.
 17. The post-operative bilateral compression device of claim 12 wherein said circumscribing sidewall is configured to present a sealing surface which extends along the post-treatment surgical site.
 18. The post-operative bilateral compression device of claim 12 further comprising an outer membrane and an inner membrane positioned adjacent to said outer membrane, wherein said outer membrane provides visibility through said postoperative bilateral compression device.
 19. The post-operative bilateral compression device of claim 12 wherein said postoperative pillow further comprises: an outer membrane; and an inner membrane positioned adjacent to said outer membrane, wherein said IFD reducing membrane separating said outer membrane and said inner membrane.
 20. The post-operative bilateral compression device of claim 12 further comprising an outer membrane and an inner membrane positioned adjacent to said outer membrane, wherein said inner membrane comprises a cooling foam.
 21. The post-operative bilateral compression device of claim 2 further comprising an outer membrane and an inner membrane positioned adjacent to said outer membrane, wherein said inner membrane comprises a cooling foam. 